OGRD MEMO #18
June 1, 1992
Washington State University
Guidelines on the Administration of Ethyl
Alcohol
in Human Experimentation
Introduction
Research on the biological and behavioral effects of the ingestion
of ethyl alcohol is often conducted on human subjects. Consistent
with the National Advisory Council on Alcohol Abuse and Alcoholism,
the University recognizes the legitimate and important need for
research involving human subjects. Only through research can we
fully understand the actions of alcohol including tolerance, dependence
and reinforcement and develop treatment programs for alcoholism.
It is essential that such research conform to the (ethical) principles
that govern all research involving human subjects. The ethical
considerations underlying the justification for using alcohol
in human research result from the fulfillment of three fundamental
principles: obtaining fully informed and voluntary consent from
the subject, insuring that benefits will result to the subject
and harm will not occur, subjects will not be compromised or manipulated.
These principles are elaborated upon in a report prepared for
the National Institute on Alcohol Abuse and Alcoholism by the
National Advisory Council on Alcohol Abuse and Alcoholism and
appear within the federal Common Rule policy for the protection
of human subjects, FR June 18, 1991, page 28003. The following
is a synopsis of those documents with excerpts from guidelines
released by the University of Washington and University of Idaho;
policy statements contained in Washington State University, OGRD
Memo #4; and the guide for students and employees entitled, "Getting
Help for Drug and Alcohol Abuse."
I. Purpose of the Guideline
The guideline is not intended to replace the functions or policies
of the IRB, University, state or federal regulations. The guideline
was prepared from the report released by the National Institute
on Alcohol Abuse and Alcoholism and other Washington and Idaho
educational institutions and is advisory only. The following general
issues deserve consideration while conducting alcohol research
involving human subjects.
A. Risk/Benefit
1. A careful appraisal of the following risk/benefit criteria
determines the appropriateness of a research protocol.
2. Normally the risks and benefits pertain to the research
subject rather than to society in total. Without a reasonable
balance, a protocol cannot be justified ethically.
3. The qualifications and experiences of the research team.
4. The site for conducting the research may influence the
risk/benefit ratio.
5. The appropriateness of the qualifications of those who
assess the risk/benefit ratio.
6. The principal responsibility for approval rests with the
IRB.
B. Informed Consent
1. The investigator has the responsibility of assuring that
the informed consent process provides the subject complete information
to make a voluntary informed decision.
2. Every informed consent should indicate that the drug, alcohol,
is a toxin and a re-enforcing agent which may cause changes in
behavior, including repetitive or excessive consumption. Everyone
who drinks alcohol is at some risk.
3. Every informed consent should indicate who is responsible
for treatment/observation periods and follow-up care.
4. The cognitive, physiologic and motivational status of the
subject is reviewed in terms of his/her ability to fully understand
the context of the informed consent.
C. Subject Selection
1. Care should be exercised to select appropriate subjects
to be used in the research.
2. Adequate safeguards are followed to prevent unnecessary
risk to the subjects.
3. The subject's age, sex, familial or genetic background,
prior alcohol or drug use, general medical or psychological condition
including alcohol recovery status are considered.
D. Confidentiality
1. Once alcohol histories are placed on charts, such charts
have to be handled with the same confidentiality afforded other
alcohol records.
2. The Code of Federal Regulations (CFR) that detail the confidentiality
requirements are followed and completely addressed in the Human
Subject Review Summary Form.
II. University Procedures for the Review and Approval of
Protocols
The responsibility for the development and implementation of research
protocols on the ingestion of ethyl alcohol rests with the principal
investigator. These procedures apply whenever research involving
alcohol in humans is conducted regardless of whether or not funds
are sought from a external agency.
When research involving human consumption of alcohol is contemplated,
it is the responsibility of the investigator to obtain a copy
of OGRD Memo#4 and the Human Subject Review Summary Form, and
provide complete information to the IRB on the following key elements.
A. Subjects: (Definition) A living individual about whom an investigator
conducting research obtains data through intervention or interaction
with the individual or identifiable private information.
B. The focus or goals of the research. (Research means the systematic
investigation, including research development, testing and evaluation,
designed to develop or contribute to generalizable knowledge).
C. Design and procedures to be used in conducting the study.
D. Potential benefits received by the individual subjects.
E. Potential risks - physical, psychological, social, legal, privacy,
or others. (Minimal Risk means that the probability and magnitude
of harm or discomfort anticipated in the research are not greater
in and of themselves than those ordinarily encountered in daily
life or during the performance of routine physical or psychological
examination or tests).
F. How will potential risks be minimized?
G. Informed consent procedures to be followed.
III. Subjects Who May Not Participate in a Study in Which
Alcohol is Consumed
A. Alcoholics who are currently choosing to abstain from alcohol
use.
B. Persons who are currently in treatment for alcoholism, problem
drinking, or alcohol-related medical problems (unless the administration
of alcohol is an integral component of the treatment of alcohol
abuse)
C. Persons who have a history of past or present drug dependency
involving substances cross-tolerant with alcohol (e.g. barbiturate
abusers)
D. Females who are pregnant.
E. Persons who have a history of adverse reactions to the type
of alcoholic beverage or the amount of alcohol to be used in the
study.
F. Persons who are presently taking medication that may interact
with alcohol.
G. Persons who are presently abusing other psychoactive substances.
H. Persons who have any type of neurological defect.
I. Minors.
IV. Project Debriefing Requirements
At the termination of the experiment, persons who have been given
enough alcohol to produce a blood level of 0.05gm% or above should
be given the choice of one of the following.
A. To be escorted by the experimenter or designated assistant
to the subject's place of residence; or
B. To remain in the laboratory setting under supervision until
such time as the blood alcohol level falls below the 0.03gm% level
(or lower if Federal guidelines require)
Subjects should be given written information concerning their
blood alcohol level at the end of an experiment. They should be
reminded of possible risks at that level and of potential problems
if they proceed to consume more alcohol. They should be given
an estimate of the number of hours before they are likely to reach
a blood alcohol level of 0.0gm%.
V. University Policy
In compliance with the Drug-Free Workplace Act of 1988, the Drug
Free Schools and Communities Act Amendments of 1989, and the State
of Washington Executive Order 92-01 establishing the Governor's
Policy on a Drug Free Work Place, a guide for students and employees
entitled, "Getting Help for Drug and Alcohol Abuse"
is provided to all faculty, staff, and students at Washington
State University. The publication contains information on University
policy, state and federal law, and resource contacts. All investigators
should be familiar with the contents of the document prior to
the development of a human subject protocol involving the administration
of ethyl alcohol.
6/1/92